Cambridge Healthtech Institute’s Inaugural

Early Detection of Disease

Assessing Opportunity and Overcoming Challenges

August 26-27, 2020


The past decade has seen remarkable progress in treating cancer and other diseases with improved diagnostic methods, but success rates of treatment would be much higher if diseases were diagnosed earlier. The Early Detection of Disease conference will delve into technologies, infrastructure, and reimbursement required to enable earlier detection of molecular conditions leading to disease progression, which will allow more effective intervention and successful outcomes. Join us for this inaugural meeting for a comprehensive view of this important topic and brainstorm ways to facilitate the revolution to early diagnosis and challenge our previous understanding about the initiation and evolution of disease.

Final Agenda

WEDNESDAY, AUGUST 26

10:30 am Registration

Plenary Keynote Session

11:30 AM Chairperson’s Remarks

11:35 Diagnostic Technologies that Will Shape Precision Medicine in 2020 and Beyond

David Walt, PhD, Hansjörg Wyss Professor, Biologically Inspired Engineering, Harvard Medical School; Professor, Department of Pathology, Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University, HHMI Professor

Precision medicine is being driven by the ability to measure biomarkers at an unprecedented scale. New technologies that enable the measurement of proteomic and genomic signatures, engineered nanomaterials for diagnostics and imaging, smart watches, and new imaging modalities provide personalized profiling that can be used to guide therapies. In order for these technologies to have the greatest benefit, there will need to be profound changes in the entire diagnostics ecosystem.

12:05 PM PANEL DISCUSSION: What Technologies Will Shape Precision Medicine in 2020?

Moderator: Susan Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia University Medical Center

Panelists: Jonathan Nowak, MD, PhD, Assistant Professor, Pathology, Harvard Medical School; Associate Pathologist, Brigham and Women’s Hospital

David Walt, PhD, Hansjörg Wyss Professor, Biologically Inspired Engineering, Harvard Medical School; Professor, Department of Pathology, Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University, HHMI Professor

What is the clinical impact of some of the following technologies and what are the current bottlenecks and challenges that need to be surmounted? Examples of each will be given:

  • RNA sequencing
  • Single-cell sequencing and analysis
  • AI and machine learning
  • Tumor mutational burden measurement
  • Emerging uses of NGS
  • Tumor microenvironment
  • Multi-modality and transcriptomics
  • Microbiome

12: 35 Plenary Keynote Introduction

Charles Mathews, Principal, ClearView Healthcare Partners

12:45-1:15 Fireside Chat

Moderator: Charles Mathews, Principal, ClearView Healthcare Partners

Sara Brenner, MD, MPH, Associate Director for Medical Affairs; CMO, In Vitro Diagnostics, Office of In Vitro Diagnostics & Radiological Health (OIR), Office of Product Evaluation & Quality (OPEQ), Center for Devices & Radiological Health (CDRH), U.S. Food & Drug Administration

1:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:45 Refreshment Break in the Exhibit Hall with Poster Viewing

OVERVIEW

2:15 Overcoming the Challenges to Realize the Opportunities of Early Disease Detection

John Sninsky, PhD, Independent Consultant, Translational Medicine and Science

Diagnosis early in the natural history of disease promises to lead to improved health management. However, over diagnosis needs to be avoided. Valuable lessons learned from cancer will be instructive for other chronic diseases. The integration of Information from multiple disparate biological compartments to generate informative probabilistic models will be paramount. How the healthcare system determines applicable evidence level and rewards value with reimbursement will be critical.

DATA AND ECONOMIC ANALYSIS

2:50 JAMA Users’ Guides to the Medical Literature: How to Read Articles That Use Machine Learning

Yun Liu, PhD, Senior Research Scientist, Google Health

Many recent clinical diagnostic tools have been developed using machine learning and must be evaluated using a 3-step process of deriving, validating, and establishing the clinical effectiveness of the tool. Several key considerations are appropriate machine learning methods used for the type and size of data, proper tuning of prespecified settings (called hyperparameters) on a dataset independent of the final validation set, and a rigorous reference standard.

3:20 Technology Valuation in the Era of Value-Based Incentives for Physician Services

John Hornberger, MD, MS, Adjunct Clinical Professor of Medicine, Stanford University

The U.S. has the highest per capita healthcare costs, with substantial financial and clinical variability due to over- and under-use of mispriced technologies (“moral hazard”). Physician-led professional societies are creating/owning quality metrics for assessing performance. Under MACRA, performance also is assessed based on costs for an episode of care. To succeed under these new incentives, physicians will need risk-based algorithms assessing technology quality and costs; representative examples to be presented.

3:50 Sponsored Presentation (Opportunity Available)

4:20 Refreshment Break in the Exhibit Hall with Poster Viewing

REIMBURSEMENT

5:05 Chairperson’s Remarks

John Sninsky, PhD, Independent Consultant, Translational Medicine and Science

5:10 Medicare: Adapting Prevention Policy for a New Molecular Era

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates LLC

Medicare has historically been far behind the curve in providing coverage for preventive services, especially novel diagnostic tests. Medicare’s approach is so slow, it risks actually discouraging investing because of the long and slow policy pipeline. Medicare can adopt new preventive benefits for diagnostics if they are directly legislated by Congress. In addition, Medicare can adopt new diagnostics through the year-long National Coverage Determination (NCD) process, if they have been previously endorsed by the U.S. Preventive Services Task Force. These serial steps can add many years to the adoption of new technology and depend on irregular multi-year timelines in the case of USPSTF. We will discuss the pros and cons of the status quo, best practices, and case studies for coping with the status quo, and the outlook for new policy that would better encourage much-needed innovations.

5:40 Lessons Learned and Challenges of Reimbursement for Early Detection of Disease

Paul Gerrard, MD, CMO & MolDX Director of Clinical Science, MolDx Palmetto

6:10 Presentation to be Announced

6:40 Close of Day

6:40 Dinner Short Course Registration*

7:00 - 9:30 Dinner Short Course*

Recommended Dinner Short Course*

SC7: Early Cancer Detection

*Separate registration required.

THURSDAY, AUGUST 27

7:15 am Registration

7:30 Problem Solving Breakout Discussions with Continental Breakfast

OPPORTUNITIES AND CHALLENGES OF EARLY DIAGNOSIS OF DISEASE

8:25 Chairperson’s Remarks

John Sninsky, PhD, Independent Consultant, Translational Medicine and Science

8:30 KEYNOTE PRESENTATION: Overdiagnosis and Premature Treatment Challenge of Early Disease Detection

Laura Esserman, MD, MBA, Professor, Surgery, University of California San Francisco Medical Center

9:00 Multi-Modal Approaches to Early Disease Detection and Population-Based Screening

Drew Watson, MBA, PhD, Biostatistics and Clinical Development Advisor

For many diseases, population screening is essential to improving patient survival. Despite the promise of blood-based “liquid biopsies”, progress has been limited necessitating new multi-omics approaches incorporating multiple technologies. We discuss new approaches to biomarker discovery, algorithm development, and clinical validation using mechanistic, statistical, and machine learning approaches for handling of multi-omics data. We further discuss the need to improve clinical decision support systems to facilitate clinical decision making.

9:30 Epigenetic Genomic Modifiers as Proxies of Gene Expression for Cancer

Alex Aravanis, MD, PhD, CSO, Head, R&D; Co-Founder, GRAIL

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

OPPORTUNITIES AND CHALLENGES OF EARLY DIAGNOSIS OF DISEASE (CONT.)

11:00 Chairperson’s Remarks

John Sninsky, PhD, Independent Consultant, Translational Medicine and Science

11:10 Opportunity for Pre-Competitive Multi-Stakeholder Collaboration for NAFLD Detection and Intervention

Veronica Miller, PhD, Executive Director, Forum for Collaborative Research; Professor (Adjunct), UC Berkeley SPH

Non-alcoholic fatty liver disease (NAFLD) affects approximately 25% of adults and 10% of children in the U.S. and is associated with obesity, type 2 diabetes mellitus, dyslipidemia and hypertension. Severe clinical outcomes include decompensated cirrhosis and hepatocellular carcinoma. The current diagnostic standard for non-alcoholic steatohepatitis (NASH), the more advanced form of NAFLD, is based on liver biopsies. Early diagnosis of the higher risk individuals is paramount. Representation and active engagement of scientific experts from all stakeholder groups in a non-competitive environment increases clarity and standardization while decreasing uncertainty. Lessons learned will be summarized.

11:25 Breast Cancer Overdiagnosis and the Precancer Problem

Alexander Borowsky, PhD, Associate Professor, Department of Pathology and Laboratory Medicine, University of California, Davis

Breast cancer screening by mammography, which began in the U.S. about 40 years ago, has led to significant increases in the incidence of early-stage breast cancers, including ductal carcinoma in situ (DCIS), also called precancer or stage 0 disease. However, the expected reciprocal decrease in subsequent late-stage breast cancers was not found. It is now clear that some screen-detected breast “cancers” are indolent lesions without significant malignant potential.

11:40 Challenges of CT Lung Screening Implementation

Andrea McKee, MD, President, Rescue Lung, Rescue Life Society; Chairman, Radiation Oncology, Lahey Hospital & Medical Center

Discussion of challenges and lessons learned from implementation of one of the largest clinical and biomarker research-integrated CT lung screening programs in the United States. Review of infrastructure required for local implementation success. Exploration of cultural and societal transformation necessary for widespread lung screening adoption.

11:55 PANEL DISCUSSION: Opportunities and Challenges of Early Diagnosis of Disease

Moderator: John Sninsky, PhD, Independent Consultant, Translational Medicine and Science

Panelists:

Alexander Borowsky, PhD, Associate Professor, Department of Pathology and Laboratory Medicine, University of California, Davis

Andrea McKee, MD, President, Rescue Lung, Rescue Life Society; Chairman, Radiation Oncology, Lahey Hospital & Medical Center

Veronica Miller, PhD, Executive Director, Forum for Collaborative Research; Professor (Adjunct), UC Berkeley SPH

12:35 pm Sponsored Presentation (Opportunity Available)

1:05 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:35 Refreshment Break in the Exhibit Hall with Poster Viewing

EARLY DETECTION OF CANCER AND BEYOND

2:15 Chairperson’s Remarks

Abhijit Patel, MD, PhD, Associate Professor, Yale University School of Medicine

2:20 Saliva Liquid Biopsy

David Wong, DMD, DMSc, Associate Dean of Research, Felix & Mildred Yip Endowed Distinguished Professor, UCLA School of Dentistry

Saliva is a bodily fluid that we produce ~600ml per day and harbors multiple omics constituents that can be harnessed non-invasively and painlessly for personalized and precision medicine, making it ideal for liquid biopsy applications. Yet, PCR-based technologies cannot detect ctDNA in saliva samples, whereas an emerging liquid biopsy platform “Electric Field Induced Release and Measurement (EFIRM)” can consistently detect ctDNA from NSCLC patients with actionable mutations in plasma and saliva with concordance of 95%+ with tissue/biopsy-based genotyping, including early stage lesions.

2:50 Plasma-Based Liquid Biopsies for Early Detection of Cancer

Nickolas Papadopoulos, PhD, Professor, Oncology and Pathology, Director of Translational Genetics, Ludwig Center for Cancer Genetics & Therapeutics, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins Institutions

Early detection of cancer has the potential to significantly reduce cancer deaths. Liquid biopsies provide an opportunity to develop tests for the detection of multiple-types of cancer in a single test. We will discuss the opportunities and the challenges of developing and utilizing such test.

EARLY DETECTION OF CANCER AND BEYOND (CONT.)

Chairperson’s Remarks

Cesar Martin Castro, MD, Director, Cancer Program; MGH Center for Systems Biology, Massachusetts General Hospital/Harvard Medical School

3:20 The Advantages and Challenges of Liquid Biopsies for Early Cancer Detection and Screening

Lynn Sorbara, PhD, Program Director, Cancer Biomarkers Research Group, National Cancer Institute (NCI), NIH

Clinical decisions are increasingly being guided by diagnostic workups, including imaging and tissue biopsies. Although tissue biopsy remains the mainstay of diagnostics, there are continuing efforts to develop non-invasive tests that could be adopted for samples acquired with minimum discomfort to patients. Liquid biopsies may be of great importance, particularly when organs of interest may not be accessible, or the patient may have other health conditions that prevent them from undergoing the procedure. These non-invasive or minimally invasive procedures may afford an opportunity to detect lesions in cases where tissue biopsy may be difficult or impossible. To date, the use of liquid biopsy in cancer risk assessment and early detection has remained at the periphery. Most of the research on liquid biopsies use blood and blood products; however, other biofluids, such as urine, sputum, saliva, stool, and cervical-vaginal fluids are being investigated. Despite all of the advantages of liquid biopsy assays, there are many challenges to overcome for successful validation and widespread use in the setting of early detection and screening.

3:50 Leveraging Novel Exosome Nanosensors for Earlier Pancreatic Cancer Detection

Cesar Martin Castro, MD, Director, Cancer Program; MGH Center for Systems Biology, Massachusetts General Hospital/Harvard Medical School

Exosomes reflect promising cancer biomarkers due to their abundance in biofluids, protein, and RNA contents reflecting parental cells, and stability in circulation. Pancreatic ductal adenocarcinomas (PDAC) represent highly lethal cancers often presenting at advanced stages. Integrating exosomes into monitoring programs for PDAC could improve clinical outcomes. This talk will discuss novel nanosensors we developed to analyze exosomes in blood and recent translational strategies to position them into clinical workflows.

4:20 End of Summit



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